UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035346
Receipt number R000040230
Scientific Title Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients
Date of disclosure of the study information 2018/12/22
Last modified on 2018/12/22 21:58:03

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Basic information

Public title

Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients

Acronym

Epidemiological characteristics of respiratory infection caused by atypical pathogens

Scientific Title

Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients

Scientific Title:Acronym

Epidemiological characteristics of respiratory infection caused by atypical pathogens

Region

Japan


Condition

Condition

Respiratory tract infection/atypical pathogen/Mycoplasma pneumoniae/Chlamydophila pneumoniae/Bordetella pertussis/Bordetella paraperutussis

Classification by specialty

Medicine in general Pneumology Infectious disease
Pediatrics Laboratory medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the epidemiological and clinical characteristics of respiratory tract infection caused by atypical pathogens in primary care patients.

Basic objectives2

Others

Basic objectives -Others

The other objectives of this study are: 1) to examine the reliability of disease probabilities for atypical pathogen infection assessed by the treating physicians, referring to the results of molecular examinations; 2) to compare the antimicrobial prescription patterns among patients with positive and negative test results for atypical pathogens; 3) to compare the antimicrobial prescription patterns between Mycoplasma pneumoniae patients with and without the macrolide resistance associated mutations; 4) to evaluate the utility of the Heckerling clinical decision rule for the diagnosis of pneumonia. This study further attempts to detect the pathogens of respiratory tract infection, analyzing the frozen residual samples with the automated molecular examination equipment.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The epidemiological characteristics of respiratory tract infection caused by atypical pathogens (Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydophila psittasi, Bordetella pertussis, Bordetella parapertussis).

Key secondary outcomes

1) The sensitivity, specificity, positive/negative predictive value, and odds ratio of the clinical signs and symptoms for the diagnosis of respiratory infection caused by different atypical pathogens.
2) The agreement between the clinical disease probabilities of atypical pathogen infection assessed by the treating physicians and the results of molecular examinations.
3) The changes in the reliability of disease probabilities assessed by the treating physicians during the study period.
4) The differences in the antimicrobial prescription patterns between patients with positive and negative test results for atypical pathogens.
5) The differences in the antimicrobial prescription patterns between Mycoplasma pneumoniae patients with and without the macrolide resistance associated mutation.
6) The sensitivity, specificity, positive/negative predictive value and odds ratio of the Heckerling clinical decision rule for the diagnosis of community-acquired pneumonia.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients are eligible for this study if all of the following criteria are met:
1) Patients are able to provide written informed consent
2) Patients have both fever (one degree higher than normal body temperature or body temperature > 37 degrees Celsius) and cough, one of which persists at least three days
3) Patients are treated by the study investigators

Key exclusion criteria

Patients are excluded if one of the following criteria is met.
1) Patients or proxies are unable to provide informed consent in Japanese
2) Patients have severe conditions (e.g., altered mental status and shock state), and sample collections are unable to be performed safely
3) Patients have chronic lung disease with multiple episodes of acute exacerbation
4) Patients have clinically evident sinusitis or tonsillitis with tonsillar exudate and swelling
5) Patients have lung tuberculosis, lung mycosis, or nontuberculous mycobacterial lung disease
6) Patients are diagnosed with hospital-acquired pneumonia or healthcare-associated pneumonia
7) Patients have dysphagia or a history of aspiration
8) Patients have obstructive pneumonia, empyema, or lung abscess

Target sample size

4000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromichi Suzuki

Organization

Tsukuba Medical Center Hospital

Division name

Division of Infectious Diseases, Department of Medicine

Zip code


Address

1-3-1, Amakubo, Tsukuba, Ibaraki, Japan

TEL

029-851-3511

Email

hsuzuki@tmch.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiromichi Suzuki

Organization

Tsukuba Medical Center Hospital

Division name

Division of Infectious Diseases, Department of Medicine

Zip code


Address

1-3-1, Amakubo, Tsukuba, Ibaraki, Japan

TEL

029-851-3511

Homepage URL


Email

hsuzuki@tmch.or.jp


Sponsor or person

Institute

Tsukuba Medical Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Toyobo

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 22 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2016 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

(Variables)
#Demographic data
Age, sex, residential status, the epidemic data of atypical pathogen infection in local communities where patients come from, close contact with cases with atypical pathogen infection, comorbidities, the history of influenza vaccination, the number of visits to hospitals/clinics, the prescribed antibiotics before examinations, smoking history

#Signs and symptoms
The progression of illness, fever, cough, sputum production, nasal obstruction, myalgia, arthralgia, headache, fatigue, chill, feverish sensation, diarrhea, vomiting

#Physical examination
Blood pressure, respiratory rate, pulse rate, body temperature, saturation of peripheral oxygen, consciousness, tonsillar swelling, tonsillar exudate, pharyngeal erythema, cervical lymphadenopathy, skin rash, an abnormal respiratory sound on chest auscultation

#Laboratory findings
Plain chest radiography, chest computed tomography, white blood cell and differential, C-reactive protein, lactate dehydrogenase, blood urea nitrogen, the results of molecular examinations*
* GENECUBE Mycoplasma, GENECUBE Chlamydia pneumoniae and GENECUBE Bordetella pertussis are used for the analysis of fresh nasopharyngeal or pharyngeal samples to detect atypical pathogens. As an additional analysis, BIOFIRE FILMARRAY multiplex PCR system and Respiratory Panel are used to identify causative pathogens of respiratory infection using frozen residual samples. Regarding the analysis of macrolide resistance, GENECUBE Mycoplasma is employed for M. pneumoiniae and BIOFIRE FILMARRAY multiplex PCR system and Respiratory Panel are applied for other pathogens.

#Others
The duration from the symptom onset to examinations, the disease probabilities of atypical pathogen infection assessed by the treating physicians, the prescribed antibiotics, a contact of swab with the posterior pharyngeal wall or the nasopharyngeal wall during sample collection, the extent of visible area in pharynx during a pharyngeal inspection


Management information

Registered date

2018 Year 12 Month 22 Day

Last modified on

2018 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040230


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name